viv1130 cygnus mkg-001 r05 101320 digital · 2020. 12. 22. · • cygnus is applied as an...

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AMNION PATCHES

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Page 1: VIV1130 Cygnus MKG-001 R05 101320 Digital · 2020. 12. 22. · • Cygnus is applied as an anatomical barrier that helps provide mechanical protection while retaining endogenous growth

AMNION PATCHES

Page 2: VIV1130 Cygnus MKG-001 R05 101320 Digital · 2020. 12. 22. · • Cygnus is applied as an anatomical barrier that helps provide mechanical protection while retaining endogenous growth

About Cygnus• Amniotic membrane is a semi-transparent and resilient membrane that lines the upper cavity of the placenta• Amniotic tissue acts as an immune-privileged protective barrier during fetal development1

• Cygnus is applied as an anatomical barrier that helps provide mechanical protection while retaining endogenous growth factors1,2,4

• The Cygnus proprietary process preserves the natural properties of amniotic tissue, maintaining inherent levels of key extracellular matrix molecules, including proteins, carbohydrates, growth factors, and cytokines5

Traditional single layer amnion allograft

Derived from the amnion layer of the placental membrane

Offered in large sizes to meet physician needs

Ideal for numerous surgical and

soft tissue applications

Flexible multilayer allograft

Derived from the amnion and chorion layers

of the placental membrane

Approximately 4X thicker than traditional

single layer amnion

Improved handling and increased workability

Providing mechanicalPROTECTION

Cygnus® is a family of amnion patch allografts that may be used as an anatomical barrier

in numerous clinical applications. The natural properties of amniotic tissue help provide

mechanical protection to damaged tissue, while the Cygnus proprietary process retains

nutrient-rich growth factors essential for signaling.1,2

0

1000

2000

3000

4000

5000

6000

7000

8000

9000

20000

30000

40000

10000

3162

8

pg

GF/

cm2

TIM

P-2

TIM

P-3HGF

VEGF A

TGF-B

1

TIM

P-4bF

GF

GRO-alph

a

TGF-B

2

MCP-1

EGF

TNF-alph

a

415

216

79 14

IMMUNE PRIVILEGED anatomical barrier1

5909

3770

1828 15

91

1498

60

180

Growth Factors Released from Cygnus Max after 24 Hours at 37° C 6

Page 3: VIV1130 Cygnus MKG-001 R05 101320 Digital · 2020. 12. 22. · • Cygnus is applied as an anatomical barrier that helps provide mechanical protection while retaining endogenous growth

Safety and Versatility• Amniotic tissue is recovered from healthy mothers who have undergone Cesarean section delivery• Cygnus is processed in accordance with FDA regulations and AATB standards• Amniotic tissue has been used for over 100 years with well-documented clinical success3

Cygnus is available in three thicknesses offering increasedversatility across a variety of physician preferences• Requires no up-front preparation• Hydrates rapidly in the surgical site• Ambient temperature storage with a 5-year shelf-life• Notch and orientation stickers to designate placement of the epithelial side upwards• E-Beam sterilization provides sterility assurance level (SAL) of 10-6

Potential Clinical Applications• Spine & Neurosurgery• Foot & Ankle• Wound Care• Burn Care• Dermatology• Ophthalmology• Oral Surgery

Maximum natural thickness allograft

Derived from the umbilical cord

Approximately 8X thicker than traditional

single layer amnion

Offers excellent handling characteristics

and the ability to be sutured

PRESERVING an array ofendogenous growth factors

Cygnus Orientation Diagram

Proper orientation for Cygnus is achieved when the

epithelial layer is facing upwards and the stromal layer

is facing downwards, as indicated by:

1) A triangular notch positioned in the upper left hand

corner of the allograft (as shown below)

2) An orientation indicator sticker located on the

inner pouch facing upwards.

INCORRECTCORRECT

Epithelial side up

Page 4: VIV1130 Cygnus MKG-001 R05 101320 Digital · 2020. 12. 22. · • Cygnus is applied as an anatomical barrier that helps provide mechanical protection while retaining endogenous growth

Trademarks™ and Registered Trademarks ® of Vivex Biologics, Inc. Copyright © 2020 Vivex Biologics, Inc. All rights reserved.

MKG-001Rev. 05

For more informationon Cygnus, please contact:

Vivex Biologics, Inc.2430 NW 116th StreetMiami, FL 33137

(888) [email protected]

1. Rowlatt, U. (1979). Intrauterine wound healing in a 20-week human fetus. Virchows Arch A Pathol Anat Histol, 381(3), 353–361.

2. Coolen, N.A. et al. (2010). Comparison between human fetal and adult skin. Archives of Dermatological Research, 302(1), 47–55.

3. Fairbairn, N.G. et al. (2014). The clinical applications of human amnion in plastic surgery, 67, 662-675.

4. Niknejad H, Peirovi H, Jorjani M, et al. Properties of the amniotic membrane for potential use in tissue engineering. Eur Cell Mater. 2008;15:88-89.

5. Delcroix GJ, Namin S, D’Ippolito G, Temple HT, Marshall R. Preserving the natural regenerative potential of amniotic membrane. Vivex Biomedical.

6. Data on file at Vivex Biologics, Inc.

The Cygnus® product line offers three different thicknesses for increased versatility for a variety of physician preferences.

CYGNUS® SOLO (THIN)SIZE CODE2x2 cm CAS020200S2x3 cm CAS020300S3x3 cm CAS030300S4x4 cm CAS040400S4x6 cm CAS040600S4x8 cm CAS040800S7x7 cm CAS070700S

CYGNUS® MATRIX (MEDIUM)SIZE CODE2x2 cm CAP020200S2x3 cm CAP020300S2x6 cm CAP020600S2x12 cm CAP021200S3x3 cm CAP030300S4x4 cm CAP040400S4x6 cm CAP040600S4x8 cm CAP040800S7x7 cm CAP070700S

CYGNUS® MAX (THICK)SIZE CODE2x2 cm CAM020200S2x3 cm CAM020300S2x4 cm CAM020400S3x3 cm CAM030300S3x4 cm CAM030400S3x5 cm CAM030500S3x6 cm CAM030600S3x8 cm CAM030800S

Product HCPCS Code: Q4170 (Cygnus) per square centimeter